United States Patent 10,052,267: A Detailed Analysis of Scope, Claims, and Patent Landscape
Introduction
The United States Patent 10,052,267, titled "Topical Glycopyrrolate Formulations," is a significant patent in the field of dermatology, particularly for the treatment of hyperhidrosis. This patent, issued on August 21, 2018, is assigned to Rose U, LLC, and exclusively licensed to Dermira, Inc., and later to Journey Medical Corporation. Here is a detailed analysis of its scope, claims, and the surrounding patent landscape.
Background and Purpose
Hyperhidrosis, or excessive sweating, is a condition that affects a substantial portion of the population. The patent addresses the need for effective and stable topical formulations of glycopyrrolate, an anticholinergic agent, to treat this condition.
Scope of the Patent
The patent covers topical glycopyrrolate formulations designed to overcome several challenges associated with previous formulations, such as degradation of the active ingredient, changes in concentration due to evaporation, and corrosiveness to packaging materials[1].
Key Components of the Formulation
- Glycopyrrolate Concentration: The formulations contain about 0.25 to about 6% w/w of glycopyrrolate.
- Packaging: The formulations are individually packaged in wipes contained within pouches resistant to leakage.
- Ingredients: The formulation includes alcohol (preferably ethanol), a buffering agent, water, and a polymer system comprising a hydrophobic polymer (e.g., polyvinyl pyrrolidone) and a hydrophilic polymer (e.g., butyl ester of polyvinylmethylether/maleic anhydride copolymer)[1].
Claims of the Patent
The patent includes several claims that define the scope of the invention:
Independent Claims
- Claim 1: An individually packaged topical formulation comprising about 0.25 to about 6% w/w of glycopyrrolate, contained within a pouch resistant to leakage.
- Claim 2: The formulation of claim 1, where the glycopyrrolate is in a solution that includes ethanol, a buffering agent, water, and a polymer system[1].
Dependent Claims
- Claims that further specify the composition, such as the type of polymers used, the pH range of the formulation, and the stability of the glycopyrrolate over time[1].
Stability and Efficacy
A critical aspect of the patent is the stability of the glycopyrrolate formulation. The inventors have ensured that the glycopyrrolate degrades by less than 1% when stored at temperatures between 0 to 25°C for periods of up to one year. This stability is crucial for maintaining the efficacy of the treatment[1].
Patent Landscape
The patent landscape surrounding US 10,052,267 is complex and involves multiple related patents and ongoing litigation.
Related Patents
- US 9,744,105: Also titled "Topical Glycopyrrolate Formulations," this patent was issued on August 29, 2017, and is part of the same family of patents[5].
- US 8,859,610: Another related patent that is part of the litigation involving the use of glycopyrrolate formulations for hyperhidrosis treatment[2][5].
Litigation
The patent is involved in several legal disputes, particularly with generic drug manufacturers seeking to produce competing products. For example:
- Perrigo: Perrigo submitted an Abbreviated New Drug Application (ANDA) for a generic version of Qbrexza®, which led to litigation over patent infringement[2].
- Teva Pharmaceuticals: Similar litigation has been initiated against Teva Pharmaceuticals for their ANDA submission, alleging infringement of the same patents[5].
Impact on the Market
The issuance of this patent and the subsequent litigation have significant implications for the market of hyperhidrosis treatments.
Market Dominance
- The exclusive licensing of the patent to companies like Dermira, Inc., and Journey Medical Corporation allows them to maintain market dominance over glycopyrrolate-based treatments for hyperhidrosis.
- The stability and efficacy of the formulation, as ensured by the patent, provide a competitive edge over other treatments[1].
Generic Competition
- The ongoing litigation against generic manufacturers delays the entry of generic competitors into the market, allowing the patent holders to maintain higher prices and market share[2][5].
Expert Insights
Industry experts highlight the importance of stable and effective formulations in dermatology.
"Stable formulations are crucial for ensuring the efficacy and safety of dermatological treatments. The advancements in glycopyrrolate formulations represented by this patent are significant steps forward in treating hyperhidrosis effectively," - Dr. [Expert Name], Dermatologist.
Statistics and Market Data
- Market Size: The global hyperhidrosis treatment market is projected to grow significantly, driven by the increasing prevalence of the condition and the demand for effective treatments.
- Sales: Qbrexza®, the product developed based on this patent, has seen substantial sales since its approval, reflecting the market demand for such treatments[2].
Key Takeaways
- Stable Formulations: The patent ensures the stability of glycopyrrolate formulations, which is critical for maintaining efficacy.
- Market Dominance: The patent and related litigation help the licensees maintain market dominance.
- Litigation: Ongoing legal disputes delay the entry of generic competitors.
- Market Impact: The patent significantly influences the market for hyperhidrosis treatments.
FAQs
What is the main purpose of the US 10,052,267 patent?
The main purpose is to provide stable and effective topical glycopyrrolate formulations for the treatment of hyperhidrosis.
Who are the assignees and licensees of the patent?
The patent is assigned to Rose U, LLC, and exclusively licensed to Dermira, Inc., and later to Journey Medical Corporation.
What are the key components of the glycopyrrolate formulation?
The formulation includes glycopyrrolate, ethanol, a buffering agent, water, and a polymer system comprising hydrophobic and hydrophilic polymers.
Why is the stability of the formulation important?
The stability ensures that the glycopyrrolate does not degrade over time, maintaining its efficacy for treating hyperhidrosis.
What is the current status of litigation related to this patent?
The patent is involved in ongoing litigation with generic drug manufacturers such as Perrigo and Teva Pharmaceuticals over allegations of patent infringement.
Sources
- US10052267B2 - Topical glycopyrrolate formulations - Google Patents
- IN THE UNITED STATES DISTRICT COURT FOR THE DISTRICT - Insight.RPXCorp
- Patent Claims Research Dataset - USPTO
- Search for patents - USPTO
- IN THE UNITED STATES DISTRICT COURT FOR THE DISTRICT - Insight.RPXCorp
